End Stage Renal Disease (ESRD) is a debilitating and financially crippling chronic disease costing healthcare systems approximately a staggering $67 B annually to treat, with incidence growing at an unmanageable rate. Hemodialysis (HD) is the predominant choice of treatment for about 85% of ESRD patients. As much as 38% of a patient's HD expenditure may not be due to dialysis but rather, due to vascular access. Vascular access remains the Achilles heel and one of the biggest unmet needs of HD.
Currently, there are three ways to obtain HD vascular access. Arteriovenous fistula (AVF) remains the gold standard with the lowest risk of complications. An arteriovenous graft (AVG) is the second option with shorter lifespan and higher risk of complication. A central catheter (CC) is often the last resort, meant only for temporary use with risk of serious complications leading to mortality. As such, preserving the health of an AVF, reducing the use of AVGs and CCs and their associated surgeries, is one of the best strategies to reduce overall cost of ESRD.
Surveying the competitive landscape, there is a missing gap in innovations impacting AVF health at the “Wear & Tear” phase—the mid stage of an AVF lifespan after the stage where it is successfully created and matured, and before the stage of onset of deterioration requiring repair interventions. Impacting AVF health at the “Wear & Tear” stage addresses fundamental mechanisms to effectively preserve AVFs than salvage downstream effects. This is also the stage where most number of preventable complications occurs due to poor cannulation.
Thus, there is a need for a delivery device for easy implantation of a subcutaneous vascular access device under the skin, and above, though not in contact with an arteriovenous fistula (referred to as AV fistula or AVF).